3796:4-2-04
Testing laboratory analysis requirements.

(A)
A testing
laboratory shall analyze a sample of at least one half of one percent of the
net weight of the batch from each batch of dried, cured plant material intended
to be sold to a dispensary licensed by the state of Ohio board of pharmacy for,
at minimum:

(B)
A
testing laboratory shall analyze a sample of at least one half of one percent
of the net weight of the batch from each batch of plant material intended to be
sold to a processor licensed by the department for use in the manufacture of
medical marijuana products for, at minimum:

(C)
A testing
laboratory shall analyze a sample of one unit of the same size, weight, and
volume intended to be packaged and sold to a licensed dispensary from each lot
of medical marijuana products prior to sale to a dispensary licensed by the
state of Ohio board of pharmacy for, at minimum:

(4)
Mycotoxin contamination, if a medical marijuana extract
was used in the manufacture of the product that was not previously tested for
mycotoxin contamination by a licensed testing laboratory;

(5)
Heavy metal
contamination including, at a minimum, arsenic, cadmium, lead, and mercury, if
a medical marijuana extract was used in the manufacture of the product that was
not previously tested for heavy metal contamination by a licensed testing
laboratory;

(6)
Pesticide and fertilizer residue, if a medical
marijuana extract was used in the manufacture of the product that was not
previously tested for pesticide or fertilizer residue contamination by a
licensed testing laboratory; and

(7)
Residual
solvents, if a hydrocarbon-based medical marijuana extract was used in the
manufacture of the product that was not previously tested for residual solvent
contamination by a licensed testing laboratory.

(D)
A testing
laboratory may perform analysis on marijuana-derived ingredients used in the
manufacture of medical marijuana products, including but not limited to medical
marijuana extract. When performing analysis on medical marijuana-derived
ingredients, the following sample sizes and required tests shall apply:

(1)
A sample of at
least one half of one percent of the net weight of the batch from a batch of
medical marijuana extract derived from a system utilizing hydrocarbon solvents
for, at minimum:

(3)
A sample of at least one half of one per cent of the
net weight of the batch from a batch of medical marijuana extract derived from
a method that does not involve the use of a hydrocarbon or carbon dioxide as a
solvent for, at a minimum:

(E)
A testing laboratory may request additional sample
material in excess of the amounts listed in this rule if necessary for
completion of the required quality assurance tests.

(F)
For the purposes
of microbial contamination analysis, a sample provided to a testing laboratory
shall be deemed to have passed if it satisfies the standards set forth in Table
9 of the "Cannabis Inflorescence: Standards of Identity, Analysis, and Quality
Control" (2014) monograph.

(1)
If a batch of plant material is not deemed to have
passed testing for microbial contamination, that batch may be designated for
extraction by hydrocarbon-based or carbon dioxide-based methods

(2)
Medical marijuana
extract derived from a batch of plant material not deemed to have passed
testing for microbial contamination must be tested for microbial contamination
prior to use in the manufacture of medical marijuana products.

(G)
For
the purposes of mycotoxin contamination analysis, a sample provided to a
testing laboratory pursuant to this rule shall be deemed to have passed
if:

(1)
The
total of the detected amounts, if any, of aflatoxin B1, aflatoxin B2, aflatoxin
G1, and aflatoxin G2 is less than twenty micrograms per kilogram;
and

(2)
The detected amount, if any, of ochratoxin A is less
than twenty micrograms per kilogram.

(H)
For the purposes
of heavy metal contamination analysis, a sample provided to a testing
laboratory shall be deemed to have passed if:

(1)
The detected
amount of arsenic, if any, is less than 0.14 micrograms per
kilogram.

(2)
The detected amount of cadmium, if any, is less than
0.09 micrograms per kilogram.

(3)
The detected
amount of lead, if any, is less than 0.29 micrograms per
kilogram.

(4)
The detected amount of mercury, if any, is less than
0.29 micrograms per kilogram.

(I)
For the purposes
of pesticide residue analysis, a sample shall be deemed to have passed if it
satisfies the most stringent acceptable standard for an approved pesticide
chemical residue in a food item as set forth in Subpart C of 40 C.F.R. Part
180, as effective on September 8, 2017. A sample shall automatically be deemed
to have failed if residue is detected from any pesticide not on the approved
pesticide list maintained by the department, regardless of the detected level
of residue.

(J)
Except as provided in paragraph (G)(1) of this rule, if
a sample is deemed to have failed tests for any contaminants listed in this
rule, the cultivator or processor that provided the sample must immediately
destroy the corresponding batch of plant material or extract or lot of medical
marijuana products and document the destruction in the inventory tracking
system.